Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT01207193
First received: September 21, 2010
Last updated: December 13, 2011
Last verified: March 2009
  Purpose

There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone, but they are most commonly seen in children and young adults while their bones are still growing. Living with a bone cyst and determining treatment options depend on the type of cyst.

Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who do not experience any symptoms.

Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the area of the bone starts to thin out. The investigators aim to assess the clinical efficacy and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.


Condition Intervention Phase
Bone Cyst
Biological: cell injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • fulfill bone cyst defect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Defect of bone due to cyst fulfill after cell transplantation.


Secondary Outcome Measures:
  • effect of mesenchymal cell transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Evaluate effect of mesenchymal cell transplantation to fulfill the defect of bone cyst.


Enrollment: 6
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bone cyst
Patients with bone cyst defect are injected with mesenchymal cells.
Biological: cell injection
injection of mesenchymal cells to bone cyst defect
Other Name: cell transplantation

Detailed Description:

Bone cysts are benign lesions usually discovered in children from age of 5 to 15 years. Treatment options include observation, corticosteroid injection and surgery. Sometimes the risk of surgery is comparable to the likelihood of fracture without treatment. In orthopedic surgery, bone chips , various types of ceramics, natural and synthetized bone mineral hydroxyapatite and tricalcium phosphate, as well as numerous polymers and co-polymers of alfa-hydroxy acids are used to perform as an osteoconductive and rarely osteoinductive factor to help bone formation.Some evidence demonstrated that bone marrow mesenchymal stem cells deposited on the surface of this constructs enhance its osteogenic differentiation. In this study the investigators seeds cultured bone marrow derived mesenchymal stem cells on bone matrix, to evaluate its therapeutic potential in repairing unicameral or aneurysmal bone cyst.This composite is placed in the bone cyst after its curettage during a surgery.Post-operation assessment is done by X-Ray examination and MRI at 1, 2, 6, and 12 months after treatment.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bone cyst diagnosed with MRI, CT-scan, or X-Ray
  • Intact cyst wall with high risk for fracture
  • Cysts with minimum diameter of 6mm
  • Diagnostic test performed on cyst fluid
  • Provided written consent form

Exclusion Criteria:

  • Patients with diagnosis of cancer
  • Patients enrolled in other clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207193

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD President of Royan Institute
Study Director: Mohammad reza Baghban Eslami Nejad, PhD Scientific Board
Principal Investigator: Mohssen Emadeddin, MD Orthopedic Investigator
Study Director: Ahmad Vosough, MD Radiologist investigator
Principal Investigator: Nasser Aghdami, MD,PhD Head of regenerativ center
  More Information

Additional Information:
No publications provided

Responsible Party: Hamid Gourabi/President of Royan Institute, Royan Institute
ClinicalTrials.gov Identifier: NCT01207193     History of Changes
Other Study ID Numbers: Royan-Bone-005
Study First Received: September 21, 2010
Last Updated: December 13, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
bone cyst bone defect mesenchymal cell

Additional relevant MeSH terms:
Bone Cysts
Cysts
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014